{ "article": { "LEGIARTI000006696829": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "27", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "1995-02-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006696829", "URL": "article/LEGI/ARTI/00/00/06/69/68/LEGIARTI000006696829.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPEBYXXXXXX027AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006694033", "@num": "L665-1", "#text": "Code de la santé publique - art. L665-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694035", "@num": "L665-2", "#text": "Code de la santé publique - art. L665-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694037", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694039", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006125452", "@fin": "2999-01-01", "#text": "CHAPITRE Ier : Dispositions relatives à la santé.", "@debut": "1995-02-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103519", "@fin": "2999-01-01", "#text": "TITRE Ier : Dispositions relatives à la santé, à la protection sociale et à l'aide sociale", "@debut": "1995-02-05" } ] }, "@cid": "JORFTEXT000000166739", "@nor": "SPSX9400133L", "@num": "95-116", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI no 95-116 du 4 février 1995 portant diverses dispositions d'ordre social (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000166739", "@c_titre_court": "Loi n°95-116 du 4 février 1995" }, { "@fin": "2999-01-01", "#text": "Loi n° 95-116 du 4 février 1995 portant diverses dispositions d'ordre social", "@debut": "1995-02-05", "@id_txt": "LEGITEXT000005617703", "@c_titre_court": "Loi n° 95-116 du 4 février 1995" } ], "@date_publi": "1995-02-05", "@date_signature": "1995-02-04" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006696829", "@fin": "2999-01-01", "@num": "27", "@etat": "VIGUEUR", "@debut": "1995-02-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
I. - (Paragraphe modificateur)
\n
II. - Le I ci-dessus entre en vigueur le 19 janvier 1994.
" } }, "LEGIARTI000006694033": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L665-1", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "1998-07-02", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006694033", "URL": "article/LEGI/ARTI/00/00/06/69/40/LEGIARTI000006694033.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X665L01AXXAD" } }, "NOTA": { "CONTENU": "
[*Nota : Ordonnance 92-1070 du 1er octobre 1992 art. 48 : le présent article du code de la santé publique, en vigueur au 7 avril 1992, s'applique à la collectivité territoriale de Mayotte.*]
\n
" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGITEXT000006076600", "#text": "Décret n°90-899 du 1 octobre 1990", "@sens": "cible", "@cidtexte": "JORFTEXT000000717086", "@nortexte": "SPSH9001578D", "@numtexte": "90-899", "@typelien": "TXT_SOURCE", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-01" }, { "@id": "LEGIARTI000006710237", "@num": "2", "#text": "Décret n°90-899 du 1 octobre 1990 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717086", "@nortexte": "SPSH9001578D", "@numtexte": "90-899", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-01" }, { "@id": "LEGIARTI000006710237", "@num": "2", "#text": "Décret n°90-899 du 1 octobre 1990 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717086", "@nortexte": "SPSH9001578D", "@numtexte": "90-899", "@typelien": "TXT_SOURCE", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-01" }, { "@id": "LEGIARTI000006697969", "@num": "48", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 48 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027505496", "@num": "Annexe", "#text": "Arrêté du 19 avril 1994 - art. Annexe (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000348356", "@nortexte": "SPSC9401292A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1994-04-19" }, { "@id": "LEGIARTI000006696829", "@num": "27", "#text": "Loi n°95-116 du 4 février 1995 - art. 27 (V) JORF 5 février 1995 en vigueur le 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000166739", "@nortexte": "SPSX9400133L", "@numtexte": "95-116", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1995-02-04" }, { "@id": "LEGIARTI000006699372", "@num": "5", "#text": "Décret n°95-292 du 16 mars 1995 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006885735", "@num": "1", "#text": "Arrêté du 10 mai 1995 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000537155", "@nortexte": "ECOC9500048A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1995-05-10" }, { "@id": "LEGIARTI000006723153", "@num": "1", "#text": "Décret n°98-239 du 27 mars 1998 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388337", "@nortexte": "MESP9820595D", "@numtexte": "98-239", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-03-27" }, { "@id": "LEGIARTI000006696344", "@num": "14", "#text": "Loi n°98-535 du 1 juillet 1998 - art. 14 () JORF 2 juillet 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000573437", "@nortexte": "MESX9702267L", "@numtexte": "98-535", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-07-01" }, { "@id": "LEGIARTI000006694035", "@num": "L665-2", "#text": "Code de la santé publique - art. L665-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801551", "@num": "R5274", "#text": "Code de la santé publique - art. R5274 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801559", "@num": "R5277-1", "#text": "Code de la santé publique - art. R5277-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155273", "@fin": "1998-07-02", "#text": "Chapitre 5 : Homologation de certains produits ou appareils.", "@debut": "1987-07-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140729", "@fin": "2000-06-22", "#text": "Titre 4 : Dispositions diverses et dispositions transitoires", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006694030", "@fin": "1991-01-20", "@num": "L665-1", "@etat": "MODIFIE", "@debut": "1987-07-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006694031", "@fin": "1994-01-19", "@num": "L665-1", "@etat": "MODIFIE", "@debut": "1991-01-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000006694032", "@fin": "1994-01-19", "@num": "L665-1", "@etat": "MODIFIE_MORT_NE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006694033", "@fin": "1998-07-02", "@num": "L665-1", "@etat": "ABROGE", "@debut": "1994-01-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les produits et appareils à usage préventif, diagnostique ou thérapeutique utilisés en médecine humaine dont l'emploi est susceptible de présenter des dangers pour le patient ou l'utilisateur, directement ou indirectement, ne peuvent être mis sur le marché à titre onéreux ou à titre gratuit s'ils n'ont reçu au préalable [*condition*] une homologation.
\n
L'autorité administrative arrête la liste des catégories de produits et appareils soumis à homologation.
\n
L'homologation ne peut être accordée que si le fabricant justifie de la conformité du produit ou appareil aux normes et aux règlements en vigueur, de la sécurité pour le patient et l'utilisateur, de la bonne adaptation à l'usage attendu du patient et de l'utilisateur et de la qualité de la fabrication.
\n
L'autorité administrative accorde l'homologation, après avis d'une commission nationale d'homologation, au fabricant ou à son représentant dûment mandaté.
\n
L'homologation n'exonère pas le fabricant ou le titulaire de l'homologation de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du produit ou appareil concerné.
\n
Un décret en Conseil d'Etat fixe les conditions relatives à l'obtention, à la durée, à l'usage et au maintien de l'homologation ainsi que les règles de procédure et la composition de la commission. Il détermine les dispositions transitoires applicables aux produits et appareils mis sur le marché avant l'entrée en vigueur de la procédure d'homologation.
\n
En cas d'infraction aux dispositions du présent article ou des textes pris pour son application, l'autorité administrative peut ordonner la suspension de la commercialisation et le retrait des produits ou appareils commercialisés [*sanctions*].
\n
Ne sont pas soumis aux dispositions du présent article les produits et appareils qui font l'objet de dispositions spécifiques du présent code.
" } }, "LEGIARTI000006694035": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L665-2", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "1998-07-02", "DATE_DEBUT": "1995-02-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006694035", "URL": "article/LEGI/ARTI/00/00/06/69/40/LEGIARTI000006694035.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X665L02AXXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006696829", "@num": "27", "#text": "Loi n°95-116 du 4 février 1995 - art. 27 (V) JORF 5 février 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000166739", "@nortexte": "SPSX9400133L", "@numtexte": "95-116", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1995-02-04" }, { "@id": "LEGIARTI000006634534", "@num": "1", "#text": "Arrêté du 16 mars 1995 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000530882", "@nortexte": "ECOC9500028A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006699368", "@num": "2", "#text": "Décret n°95-292 du 16 mars 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006731817", "@num": "2", "#text": "Arrêté du 14 mai 1996 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000376989", "@nortexte": "FCEC9600091A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-05-14" }, { "@id": "LEGIARTI000006733023", "@num": "2", "#text": "Arrêté du 28 mai 1997 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000749872", "@nortexte": "FCEC9700092A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1997-05-28" }, { "@id": "LEGIARTI000006727239", "@num": "2", "#text": "Arrêté du 28 mai 1998 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000389877", "@nortexte": "ECOC9800054A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1998-05-28" }, { "@id": "LEGIARTI000006696344", "@num": "14", "#text": "Loi n°98-535 du 1 juillet 1998 - art. 14 () JORF 2 juillet 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000573437", "@nortexte": "MESX9702267L", "@numtexte": "98-535", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-07-01" }, { "@id": "LEGIARTI000006694030", "@num": "L665-1", "#text": "Code de la santé publique - art. L665-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694038", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155273", "@fin": "1998-07-02", "#text": "Chapitre 5 : Homologation de certains produits ou appareils.", "@debut": "1987-07-25" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140729", "@fin": "2000-06-22", "#text": "Titre 4 : Dispositions diverses et dispositions transitoires", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006694034", "@fin": "1995-02-05", "@num": "L665-2", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006694035", "@fin": "1998-07-02", "@num": "L665-2", "@etat": "ABROGE", "@debut": "1995-02-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La mise sur le marché est autorisée selon les dispositions de l'article L. 665-4. Toutefois, restent applicables :
\n
1° Pour les dispositifs médicaux implantables actifs, jusqu'au 31 décembre 1994, les dispositions de l'article L. 665-1 ;
\n
2° Pour les autres dispositifs médicaux, à compter du 1er janvier 1995 et jusqu'au 13 juin 1998, la réglementation à laquelle ils étaient soumis au 31 décembre 1994.
" } }, "LEGIARTI000006694037": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L665-3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2000-06-22", "DATE_DEBUT": "1995-02-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006694037", "URL": "article/LEGI/ARTI/00/00/06/69/40/LEGIARTI000006694037.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X665L03AXXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006696829", "@num": "27", "#text": "Loi n°95-116 du 4 février 1995 - art. 27 (V) JORF 5 février 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000166739", "@nortexte": "SPSX9400133L", "@numtexte": "95-116", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1995-02-04" }, { "@id": "LEGITEXT000005618050", "#text": "Décret n°95-292 du 16 mars 1995", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "TXT_SOURCE", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006699368", "@num": "2", "#text": "Décret n°95-292 du 16 mars 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "TXT_SOURCE", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006699369", "@num": "3", "#text": "Décret n°95-292 du 16 mars 1995 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "TXT_SOURCE", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006699372", "@num": "5", "#text": "Décret n°95-292 du 16 mars 1995 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "TXT_SOURCE", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006684267", "@num": "Annexe III", "#text": "Décret n°99-316 du 26 avril 1999 - art. Annexe III (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000211160", "@nortexte": "MESA9921082D", "@numtexte": "99-316", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-04-26" }, { "@id": "LEGIARTI000006631930", "@num": "2", "#text": "Décret n°99-1046 du 13 décembre 1999 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000580255", "@nortexte": "ECOI9900400D", "@numtexte": "99-1046", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-12-13" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15 art. 4 I JORF 22 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "ABROGATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006726135", "@num": "6", "#text": "Décret n°2004-802 du 29 juillet 2004 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000421679", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694049", "@num": "L665-7-1", "#text": "Code de la santé publique - art. L665-7-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695148", "@num": "L731-2", "#text": "Code de la santé publique - art. L731-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801574", "@num": "R665-1", "#text": "Code de la santé publique - art. R665-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801701", "@num": "R665-48", "#text": "Code de la santé publique - art. R665-48 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006804252", "@num": "R791-4-2", "#text": "Code de la santé publique - art. R791-4-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006804254", "@num": "R791-4-4", "#text": "Code de la santé publique - art. R791-4-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006804256", "@num": "R791-4-5", "#text": "Code de la santé publique - art. R791-4-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006804257", "@num": "R791-4-6", "#text": "Code de la santé publique - art. R791-4-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006140730", "@fin": "2000-06-22", "#text": "Chapitre 1 : Dispositions générales", "@debut": "1994-01-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125382", "@fin": "2000-06-22", "#text": "Livre 5 bis : Dispositions relatives aux dispositifs médicaux", "@debut": "1994-01-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006694036", "@fin": "1995-02-05", "@num": "L665-3", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006694037", "@fin": "2000-06-22", "@num": "L665-3", "@etat": "ABROGE", "@debut": "1995-02-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine ou autre article utilisé seul ou en association, y compris les accessoires et logiciels intervenant dans son fonctionnement, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens.
\n
Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.
" } }, "LEGIARTI000006694039": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L665-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1998-07-02", "DATE_DEBUT": "1995-02-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006694039", "URL": "article/LEGI/ARTI/00/00/06/69/40/LEGIARTI000006694039.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X665L04AXXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006696829", "@num": "27", "#text": "Loi n°95-116 du 4 février 1995 - art. 27 (V) JORF 5 février 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000166739", "@nortexte": "SPSX9400133L", "@numtexte": "95-116", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1995-02-04" }, { "@id": "LEGIARTI000006699372", "@num": "5", "#text": "Décret n°95-292 du 16 mars 1995 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000350606", "@nortexte": "SPSH9500005D", "@numtexte": "95-292", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-16" }, { "@id": "LEGIARTI000006731817", "@num": "2", "#text": "Arrêté du 14 mai 1996 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000376989", "@nortexte": "FCEC9600091A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-05-14" }, { "@id": "LEGIARTI000006733023", "@num": "2", "#text": "Arrêté du 28 mai 1997 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000749872", "@nortexte": "FCEC9700092A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1997-05-28" }, { "@id": "LEGIARTI000006723153", "@num": "1", "#text": "Décret n°98-239 du 27 mars 1998 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388337", "@nortexte": "MESP9820595D", "@numtexte": "98-239", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-03-27" }, { "@id": "LEGIARTI000006727239", "@num": "2", "#text": "Arrêté du 28 mai 1998 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000389877", "@nortexte": "ECOC9800054A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1998-05-28" }, { "@id": "LEGIARTI000006690286", "@num": "L5211-3", "#text": "Code de la santé publique - art. L5211-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694035", "@num": "L665-2", "#text": "Code de la santé publique - art. L665-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694041", "@num": "L665-4-1", "#text": "Code de la santé publique - art. L665-4-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694047", "@num": "L665-7", "#text": "Code de la santé publique - art. L665-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694051", "@num": "L665-8", "#text": "Code de la santé publique - art. L665-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694053", "@num": "L665-9", "#text": "Code de la santé publique - art. L665-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801608", "@num": "R665-12", "#text": "Code de la santé publique - art. R665-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006140730", "@fin": "2000-06-22", "#text": "Chapitre 1 : Dispositions générales", "@debut": "1994-01-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125382", "@fin": "2000-06-22", "#text": "Livre 5 bis : Dispositions relatives aux dispositifs médicaux", "@debut": "1994-01-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006694038", "@fin": "1995-02-05", "@num": "L665-4", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006694039", "@fin": "1998-07-02", "@num": "L665-4", "@etat": "MODIFIE", "@debut": "1995-02-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006694040", "@fin": "2000-06-22", "@num": "L665-4", "@etat": "ABROGE", "@debut": "1998-07-02", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux ne peuvent [*obligation*] être importés, mis sur le marché, mis en service ni utilisés dans le cadre d'investigations cliniques s'ils n'ont reçu, au préalable, un certificat attestant leurs performances ainsi que leur conformité à des exigences essentielles concernant la sécurité et la santé des patients, des utilisateurs et des tiers.
\n
La certification de conformité est établie par le fabricant lui-même ou par des organismes désignés par l'autorité administrative.
\n
Un décret en Conseil d'Etat détermine les catégories de dispositifs et les procédures de certification qui leur sont applicables ainsi que, le cas échéant, la durée pendant laquelle la certification est valable.
" } } }, "article_lien": [ { "article_id": "LEGIARTI000006694033", "cible": false, "cidtexte": "JORFTEXT000000166739", "id": "LEGIARTI000006696829", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006694035", "cible": false, "cidtexte": "JORFTEXT000000166739", "id": "LEGIARTI000006696829", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006694039", "cible": false, "cidtexte": "JORFTEXT000000166739", "id": "LEGIARTI000006696829", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006694037", "cible": false, "cidtexte": "JORFTEXT000000166739", "id": "LEGIARTI000006696829", "typelien": "MODIFICATION" } ], "follow": [ "LIENS.LIEN[@sens=cible,@typelien=CREATION].@id" ], "id": "LEGIARTI000006696829", "liens_entrants": true }

Article 27 AUTONOME VIGUEUR, en vigueur depuis le 05/02/1995 (LOI no 95-116 du 4 février 1995 portant diverses dispositions d'ordre social (1))